Manufacturing Operator 1

Integra LifeSciences

74d • $19 - $25

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. This Manufacturing Operator I will perform initial chemical processing and batch mixing such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen prep, dispersion prep and lyophilization required to produce collagen-based products. Performs the set up, and operates all clean room manufacturing equipment. All work streams include responsibility in the setup, operation and cleaning of all clean room manufacturing equipment. All chemical processing operations are performed in ISO Class 5 or ISO Class 7 areas and require proper Clean Room gowning. All processing is performed in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s) and Health and Safety requirements. Operate in a team environment focused on daily milestones and quality throughput. This role is a Monday through Thursday 6 AM to 4:30 PM.

Requirements

• High School diploma or equivalent.
• Degree in related science.
• 0 - 2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry.
• Production experience in a clean room environment is highly desirable.
• Basic computer skills for email and data entry.
• Must read, write and speak in English, and communicate clearly and concisely.
• Fundamental understanding of mathematics and chemistry.
• Ability to participate in a team-oriented environment and assist/train others.
• Ability to work independently with minimal supervision.
• Ability to operate, maintain and troubleshoot process equipment, and make minor adjustments as needed.
• Ability to gown to ISO Class 5 and 7 Clean Room standards.
• Ability to work overtime.

Responsibilities

• Operate, maintain, and troubleshoot process equipment utilized in the collagen business.
• Perform precise measurements and use measurement equipment to accurately add chemicals to batches.
• Blend, mix, pour, and load collagen prepped material into lyophilizing equipment.
• Pass and maintain gowning qualification for ISO Class 5 and 7 Clean room operations.
• Maintain legible and accurate records, required logs, books, and other procedures to comply with regulatory requirements.
• Interface with QA/QC/Material departments to coordinate inspections and efficient flow of subassemblies and completed product.
• Enter and record production activities in Oracle MRP systems.
• Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements.
• Handle, decontaminate, and clean production supplies, instruments, and equipment.
• Report all discrepancies to the Supervisor or Group Leader.
• Support department and plant Safety goals by demonstrating safe behavior.
• Maintain a clean and orderly work area.
• Work flexible shifts and days to meet batch milestone requirements.
• Perform other manufacturing activities as assigned by department leadership.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability
• Business accident insurance
• Group legal insurance
• 401(k) savings plan

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees